Contact information
Type
Scientific
Primary contact
Dr Lindsay Smith
ORCID ID
Contact details
East Somerset Research Consortium
Westlake Surgery
High Street
West Coker
BA22 9AH
United Kingdom
+44 (0)1935 862624
research@esrec.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R/29/10.99/Smith
Study information
Scientific title
Acronym
MIST
Study hypothesis
Main research question: Which of three management methods (expectant, medical or surgical) of failed first trimester pregnancy (missed or incomplete miscarriage) is associated with least gynaecological infection.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pregnancy; miscarriage
Intervention
1. Expectant management
2. Medical management
3. Surgical management
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Gynaecological infection within 14 days of randomisation.
Secondary outcome measures
1. Bleeding & pain
2. Retained products by scan at 10-14 days
3. Depression
4. Anxiety
5. Return to normal activity
6. Complications by 6 weeks
Overall trial start date
01/04/1997
Overall trial end date
31/10/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women with a failed pregnancy of <13 weeks gestation
2. Attending the early pregnancy assessment clinics of Southmead Hospital, Bristol or the Royal United Hospital, Bath
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1200 women were recruited: 399 to expectant management, 398 to medical management, and 403 to surgical management (added 12/01/10, see publication)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/04/1997
Recruitment end date
31/10/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
East Somerset Research Consortium
West Coker
BA22 9AH
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South West (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16707509
2. 2006 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/16827823
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19815581
Publication citations
-
Results
Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L, Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial)., BMJ, 2006, 332, 7552, 1235-1240, doi: 10.1136/bmj.38828.593125.55.
-
Economic evaluation
Petrou S, Trinder J, Brocklehurst P, Smith L, Economic evaluation of alternative management methods of first-trimester miscarriage based on results from the MIST trial., BJOG, 2006, 113, 8, 879-889, doi: 10.1111/j.1471-0528.2006.00998.x.
-
Results
Smith LF, Ewings PD, Quinlan C, Incidence of pregnancy after expectant, medical, or surgical management of spontaneous first trimester miscarriage: long term follow-up of miscarriage treatment (MIST) randomised controlled trial., BMJ, 2009, 339, b3827.